SleepEasy
Would you like a free travel bag for your SleepEasy? If so, go to http://sleepeasy.respironics.com/register to register your product and receive your SleepEasy travel bag. A nominal charge for shipping and handling will be applied. This SleepEasy device is covered by one or more of the following patents: U.S. Patent No. 6,622,724. Other U.S. and Foreign Patents Pending. 2007 Respironics, Inc. and its affiliates. All rights reserved.
Table of Contents Chapter 1: Introduction...1 1.1 System Contents...1 1.2 Intended Use...2 1.3 Warnings, Cautions, and Contraindications... 2 1.3.1 Warnings...2 1.3.2 Cautions...4 1.3.3 Contraindications...4 1.4 System Overview...5 1.4.1 Breathing Circuit Overview...7 1.5 Glossary...7 1.6 Symbol Key...8 1.7 How to Contact Respironics...8 Chapter 2: Device Controls and Displays...9 2.1 Control Buttons...9 2.2 Display...9 2.3 LED Backlight...10 2.4 Control Panel Inactivity...10 Chapter 3: Setup...11 3.1 Installing the Air Filters...11 3.2 Where to Place the Device...12 3.3 Connecting the Breathing Circuit...12 3.4 Supplying AC Power to the Device...14 3.5 Setup the Integrated Humidifier...14 3.6 Setup Example...16 i
Chapter 4: Device Operation...17 4.1 Starting the Device...17 4.2 Using the Ramp Feature...18 4.2.1 Ramp Feature...18 4.2.2 Setting Ramp...18 4.3 Using the Heated Humidifier Feature...19 4.3.1 Heated Humidifier Feature...19 4.3.2 Setting Heated Humidifier...19 4.4 Altitude Setting...19 4.5 Display Screens...20 4.5.1 Navigating the Display Screens...20 4.5.2 Viewing Data on the Patient Data Screens...20 4.6 System Error Screen...21 Chapter 5: Alerts and Troubleshooting...22 5.1 Device Alerts...22 5.2 Troubleshooting...22 Chapter 6: Accessories...25 6.1 Adding Supplemental Oxygen...25 6.2 Traveling with the System...26 6.2.1 International Travel...26 Chapter 7: Cleaning and Maintenance...27 7.1 Cleaning the Device...27 7.2 Cleaning or Replacing the Filters...27 7.3 Cleaning the Tubing...28 7.4 Cleaning the Water Chamber...28 7.5 Service...29 Chapter 8: Specifications...30 Appendix A: EMC Information...32 ii
Chapter 1: Introduction This chapter provides information on: SleepEasy system contents Intended Use Warnings, cautions, and contraindications System overview Glossary and symbol key How to contact Respironics 1.1 System Contents Your SleepEasy system includes the following items: Disposable White Ultra-fine Filter Reusable Gray Foam Filter Funnel AC Power Cord Protective Cover Flexible Tubing SleepEasy Device with integrated Humidifier Figure 1 1 System Contents NOTE: If any of the above items are missing, contact your home care provider. 1
1.2 Intended Use The Respironics SleepEasy device delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing >66 lbs. It is intended for use in the home or hospital environment. Your home care provider will make the correct pressure settings according to your health care professional s prescription. Several accessories are available to make your OSA treatment with the SleepEasy system as convenient and comfortable as possible. To ensure that you receive the safe, effective therapy prescribed for you, use only Respironics accessories. 1.3 Wa r n i n g s, Ca u t i o n s, a n d Contraindications CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician. Read all instructions before using the SleepEasy device with integrated humidifier. 1.3.1 Wa r n i n g s A warning indicates the possibility of injury to the user or the operator. This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professional s instructions regarding the use of the device. The operator should read and understand this entire manual before using the device. This device is not intended for life support. The device should be used only with masks and connectors recommended by Respironics or with those recommended by the health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked. Explanation of the Warning: The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask exhalation port. However, when the device is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. Do not use this device without the water chamber in place. This device contains small parts which could present a choking hazard. Do not use extension cords with this device. If oxygen is used with the device, turn on the device before you turn on the oxygen flow. Also, the oxygen flow must be turned off when the device is not in use. Explanation of the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device s enclosure. Oxygen accumulated in the device enclosure will create a risk of fire. Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. 2
When using oxygen with this system, a Respironics Pressure Valve must be placed in-line with the patient circuit. Failure to use the pressure valve could result in a fire hazard. Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide. Do not use the device near a source of toxic or harmful vapors. Do not use this device if the room temperature is warmer than 95 F. If the device is used at room temperatures warmer than 95 F, the temperature of the airflow may exceed 106 F. This could cause irritation or injury to your airway. Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device. Contact your health care professional if symptoms of sleep apnea recur. If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, or if the enclosure is broken, discontinue use and contact your home care provider. Repairs and adjustments must be performed by Respironics-authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage. Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace if damaged. To avoid electric shock, unplug the device before cleaning it. DO NOT immerse the device in any fluids. Using this device at an incorrect altitude setting could result in airflow pressures higher or lower than the prescribed setting. Always verify the altitude setting when traveling or relocating, and adjust the system accordingly. Pins of connectors identified with the ESD warning symbol ( )should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up of electrostatic discharge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing), discharging one s body to the frame of the equipment or system or to earth or a large metal object, and bonding oneself by means of a wrist strap to the equipment or system or to earth. Never operate the device if any of the parts are damaged, or if it is not working properly. Do not use the device if the water chamber is leaking or damaged in any way. Have any damaged parts replaced before continuing use. Never touch the heater plate unless the unit is unplugged and the plate has cooled down. While the device is in operation, the soft flap on the flapper valve must move freely and close off the opening on top of the water chamber. Replace the flapper valve if the flap is damaged or not intact. When installing the water chamber onto the system, do not allow any water to spill into the CPAP device. When installing the water chamber onto the system, make sure the soft valve is first attached to the water chamber. 3
1.3.2 Ca u t i o n s A Caution indicates the possibility of damage to the device. The device may only be operated at temperatures between 41 F and 95 F. If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the operating temperature range shown in Chapter 8. Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter. Do not place the device in or on any container that can collect or hold water. Make sure that the drain holes on the bottom of the device are not blocked. Condensation may damage the device. Always allow the device to reach room temperature before use. A properly installed, undamaged reusable foam inlet filter is required for proper operation. Tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning. If fluids are spilled onto the heater plate, unplug the power cord from the AC wall outlet and allow the device to drain and dry before using. Take precautions to protect furniture from water damage. Use distilled water only in the chamber. Do not fill water chamber above the fill line indicated on the side of the water chamber. Make sure the protective cover is securely fastened on top of the water chamber before operating the device. NOTE: Additional warnings, cautions, and notes are located throughout this manual. 1.3.3 Contraindications When assessing the relative risks and benefits of using this equipment, the clinician should understand that this device can deliver pressures up to 20 cm H 2 O. In the event of certain fault conditions, a maximum pressure of 35 cm H 2 O is possible. Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients: Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Pneumothorax Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426) The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection. Not for use with patients whose upper airways are bypassed. Contact your physician if you have any questions concerning your therapy. 4
1.4 System Overview The SleepEasy device, shown in Figure 1 2, is a sleep apnea system that delivers Continuous Positive Airway Pressure (CPAP). CPAP maintains a constant level of pressure throughout the breathing cycle. Several accessories are also available for use with your SleepEasy device. Contact your home care provider to purchase any accessories not included with your system. Figure 1 2 SleepEasy Device Figure 1 3 illustrates many of the device features, described in the following table. Power Inlet (back of unit) Display Screen Heated Humidifier Button Flapper (Soft) Valve Air Inlet Port Protective Cover Ramp Button Start/Stop Button Fill Line Heater Plate Air Outlet Port Water Chamber Figure 1 3 System Overview 5
Display Screen Device Feature Description Heated Humidifier Button Ramp Button Start/Stop Button Heater Plate Air Outlet Port Water Chamber Fill Line Protective Cover Flapper Valve Power Inlet Medical Equipment Note (bottom of unit) Filter Area (back of unit) Shows therapy settings, patient data, and error messages. This button controls the humidifier functions. This button starts or restarts the ramp cycle. This button starts or stops the airflow and the heater plate (if activated). Warms the water in the water chamber. Connect the flexible tubing here. The removable water chamber holds the water for humidification. This indicates the maximum water level for safe operation. Clip on top of the water chamber to prevent debris from entering the water chamber. This valve helps prevent water from splashing into the device. Connect the power cord here. For ease at airport security stations, there is a note on the bottom of the device stating that it is medical equipment. It may help if you also take this manual with you when you travel. A reusable, gray foam filter must be placed in the filter area to screen out normal household dust and pollens. An optional, white ultra-fine filter can also be used for more complete filtration of very fine particles. 6
1.4.1 Breathing Circuit Overview The patient breathing circuit, shown in Figure 1 4, consists of the following: Circuit tubing to deliver air from the device to your interface (e.g., mask) A mask or other patient interface device to deliver the prescribed pressure to your nose or nose and mouth, depending on which interface has been prescribed for you An exhalation device to vent exhaled air from the circuit Patient Interface Exhalation Device Circuit Tubing Exhalation Port Mask's Connector Flexible Tubing Connector Circuit with Separate Exhalation Device Circuit with Mask with Integrated Exhalation Port Figure 1 4 Typical Breathing Circuits NOTE: The exhalation port may be part of the interface or may be part of a separate exhalation device, but is required to minimize the potential for CO 2 rebreathing. 1.5 Gl o s s a r y The following terms and acronyms appear throughout this manual: Te r m/ac r o n y m Active State Apnea CPAP OSA Ramp Safe State Standby State Definition The state of the device when power is applied, the airflow is on, and the device is providing therapy. A condition marked by the cessation of spontaneous breathing. Continuous Positive Airway Pressure Obstructive Sleep Apnea A feature that may increase patient comfort when therapy is started. The ramp feature reduces pressure and then gradually increases the pressure to the prescription setting so you can fall asleep more comfortably. The state in which the device does not provide therapy. The device enters this state if an error is detected. The state of the device when power is applied but the airflow and humidification is turned off. 7
1.6 Sy m b o l Ke y The following symbols appear on the device: Sy m b o l Definition Consult accompanying instructions for use. Type BF Applied Part Class II (Double Insulated) IPX1 Drip Proof Equipment Electrostatic Discharge Canadian/US Safety Certification Hot Surface Caution Serial Interface Maximum Fill Line 1.7 Ho w t o Co n t a c t Respironics To have your device serviced, contact your home care provider. If you need to contact Respironics directly, call the Respironics Customer Service department at 1-800-345-6443 (US and Canada only) or 1-724-387-4000. You can also use the following address: Respironics 1001 Murry Ridge Lane Murrysville, PA 15668 Visit Respironics web site at: www.respironics.com. 8
Chapter 2: Device Controls and Displays This chapter describes the device s control buttons and displays, patient circuit connections, and rear panel connections. 2.1 Controls Buttons Figure 2 1 shows the five primary control buttons on the SleepEasy device. Display Screen User Buttons Heated Humidifier Button Ramp Button Start/Stop Button Bu t t o n Figure 2 1 Primary Control Buttons These buttons are described below. Description Starts the airflow and places the device into Active state, or stops the airflow, and places the device into Standby state. It is also used to exit any display screen. Controls the humidifier functions. When the airflow is on, this button allows you to activate or restart the ramp function. Ramp lowers the airflow pressure and then gradually increases it, allowing you to fall asleep more easily. + Performs next screen navigation or increases setting. - Performs previous screen navigation or decreases setting. 2.2 Di s p l a y Figure 2 2 shows the display screen. Figure 2 2 Display Screen 9
The information shown on the display screen is defined as follows: Ic o n Description Indicates that the Blower Hours or the User Hours Time Meter is being displayed. Indicates that the Therapy Hours Time Meter is being displayed. When displayed with the Therapy Hours icon, it indicates that the Session Counter is being displayed. Indicates that the Altitude Level is being displayed. Indicates that the humidifier is providing heat. Indicates that the unit is in the Provider Settings Menu. In Active State, indicates that the Ramp function is in progress. In menus, it is used to indicate Ramp Time Setting alone, or in combination with Ramp Start Pressure. Indicates that the Ramp Start Pressure is being displayed. Indicates that a pressure value is being displayed. Indicates that the user may erase the displayed data. Indicates that the unit requires user attention. Indicates that the unit requires user attention. Indicates that the Compliance Checksum for the unit is being displayed. 2.3 LED Ba c k l i g h t The START/STOP, HEAT and RAMP buttons are lit by LED backlights. The START/STOP LED will always be on when power is applied to the device. The HEAT LED is on when the humidifier heater plate is active, and off when it is not. The RAMP LED is on when the ramp function is active and off when it is not. 2.4 Control Panel Inactivity Some screens have time-out periods. The screen s timer starts when the screen is initially displayed and is restarted whenever a button is pressed. Unless otherwise specified, all screens timeout after one minute and will return to the Inactive Display. If in Provider Mode, the unit will additionally exit Provider Mode. 10
Chapter 3: Setup This chapter provides instructions on how to: Install the air filters Position the device Connect the breathing circuit Supply power to the device Setup the integrated humidifier 3.1 Installing the Air Filters CAUTION: A properly installed, undamaged foam filter is required for proper operation. The device uses a gray foam filter that is washable and reusable, and an optional white ultra-fine filter that is disposable. The reusable filter screens out normal household dust and pollens, while the optional ultra-fine filter provides more complete filtration of very fine particles. The gray reusable filter must be in place at all times when the device is operating. The ultra-fine filter is recommended for people who are sensitive to tobacco smoke or other small particles. A reusable gray foam filter and a disposable ultra-fine filter are supplied with the device. If your filters are not already installed when you receive your device, you must at least install the reusable gray foam filter before using the device. To install the filter(s): 1. If you are using the white disposable ultra-fine filter, insert it into the filter area first, meshside facing in, towards the device. 2. Insert the gray foam filter into the filter area as shown in Figure 3 1. NOTE: If you are not using the white disposable filter, simply insert the gray foam filter into the filter area. AC Inlet Filter Area Disposable White Ultra-fine Filter (optional) Reusable Gray Foam Filter (required) Figure 3 1 Installing the Air Filter NOTE: See Chapter 7, Cleaning and Maintenance, for information on how to clean or replace the air filters. 11
3.2 Where to Place the Device Place the device on a firm, flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position. Make sure the filter area on the back of the device is not blocked by bedding, curtains, or other items. Air must flow freely around the device for the system to work properly. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners). CAUTION: Do not place the device directly onto carpet, fabric, or other flammable materials. CAUTION: Do not place the device in or on any container that can collect or hold water. CAUTION: Make sure that the drain holes on the bottom of the device are not blocked. CAUTION: Take precautions to protect furniture from water damage. CAUTION: Do not turn the device on without the water chamber installed. 3.3 Connecting the Breathing Circuit To use the system, you will need the following accessories in order to assemble the recommended circuit: Respironics interface (e.g, nasal mask or full face mask) with integrated exhalation port (or Respironics interface with a separate exhalation device such as the Whisper Swivel II) Respironics 6 ft. flexible tubing Respironics headgear (for the patient interface) WARNING: If the device is used by multiple persons (e.g., rental devices), a low-resistance, main flow bacteria filter should be installed in-line between the device and the circuit tubing to prevent contamination. To connect your breathing circuit to the device, complete the following steps: 1. Connect the flexible tubing to the air outlet on the top of the device, as shown in Figure 3 2. Flexible Tubing Bacterial Filter (optional) Figure 3 2 Connecting the Flexible Tubing 12
NOTE: If required, connect a bacteria filter to the device air outlet, and then connect the flexible tubing to the outlet of the bacteria filter. NOTE: The bacteria filter is recommended to protect the patient, care provider and equipment from the transference of a virus or bacteria through the breathing circuit. 2. Connect the tubing to the mask: a. If you are using a mask with a built-in exhalation port, connect the mask s connector to the flexible tubing, as shown in Figure 3 3. Exhalation Port Mask's Connector Flexible Tubing Connector Figure 3 3 Connecting a Mask with Built -in Exhalation Port b. If you are using a mask with a separate exhalation device, connect the open end of the flexible tubing to the exhalation device as shown in Figure 3 4. Position the exhalation device so that the vented air is blowing away from your face. Connect the mask s connector to the exhalation device. Exhalation Device Flexible Tubing Connector Figure 3 4 Connecting a Mask with a Separate Exhalation Device WARNING: The exhalation device (e.g., Whisper Swivel II) or exhalation port (on masks with an integrated exhalation port) is designed to exhaust CO 2 from the patient circuit. Do not block or seal the ports on the exhalation device. WARNING: If you are using a full face mask (i.e., a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve. You must ensure that the entrainment valve is functioning properly. 3. Attach the headgear to the mask. See the instructions that came with your headgear. 13
3.4 Supplying AC Power to the Device CAUTION: If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before beginning the following setup procedures. Do not operate the device outside of the operating temperature range shown in Chapter 8. WARNING: Route the wires to avoid tripping. WARNING: This device is activated when the power cord is connected. Pressing the turns the airflow and humidifier (if activated) on or off. Complete the following steps to operate the device using AC power. button 1. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch. 2. Plug the power cord s connector into the power inlet on the back of the device, as shown in Figure 3 5. AC Inlet (back of unit) Power Cord Filter Area 3. Ensure that all connections are secure. Figure 3 5 Connecting the Power Cord to the Device IMPORTANT: To remove AC power, disconnect the power cord from the electrical outlet. WARNING: Inspect the power cord often for any signs of damage. Replace a damaged power cord immediately. WARNING: Do not use extension cords with this device. 3.5 Setup the Integrated Humidifier WARNING: Do not use the SleepEasy device without the water chamber in place. First Use 1. Slide the water chamber out from the side of the unit. 14
2. Gently remove the base of the chamber with your hands, being careful not to damage the rubber seal. 3. Remove the flapper valve from the air inlet port; unclip the protective cover from the top of the water chamber, as shown in Figure 3-6. Wash these parts by hand only in a solution of warm water and mild liquid dishwashing soap. Rinse the parts with clean water and allow them to air dry. Protective Cover Flapper Valve Soft Flap Figure 3 6 Flapper Valve and Protective Cover 4. Wash the water chamber and heater plate in the dishwasher (top shelf only) or by hand in a solution of warm water and mild dishwashing soap. 5. Reassemble. Insert the flapper valve into the air inlet port, and clip the protective cover on top of the water chamber, as shown in Figure 3-6. 6. Fill the chamber to the fill line with distilled water. CAUTION: Use only distilled water in the chamber. 7. Slide the chamber into place on the side of the unit. Continue as instructed in Step 5 of Daily Use. Daily Use 1. Slide the water chamber out from the side of the unit. 2. Before each use, check the flapper valve operation. Visually inspect the soft flap to make sure it is free to open and close when installed in the water chamber. Check to make sure the soft flap is not pushed back into the flapper valve. Replace the valve if the soft flap is damaged or missing. Make sure the protective cover is clipped into place on top of the water chamber. 3. Before each use, rinse the chamber with water. Fill the chamber to the fill line with distilled water using the funnel, as shown in Figure 3-7. Fill Line Figure 3 7 Filling the Water Chamber 15
CAUTION: Use only distilled water in the chamber. CAUTION: Do not overfill the water chamber. Damage to the therapy device may occur. CAUTION: Do not allow the water chamber to sit for any length of time after it has been filled with water. Immediately install the chamber in the device (step 4). Allowing water to sit in the chamber (when the chamber is not installed in the device) may cause the chamber to separate from the bottom plate and may cause water leakage. 4. Slide the chamber into place on the side of the unit. WARNING: Do not touch the heater plate with your hands. CAUTION: Avoid moving the device when the water chamber has water in it. 5. Connect the flexible tubing (included with your therapy device system) to the outlet port on the water chamber. IMPORTANT: Before each use, examine the flexible tubing for any kinks, damage, or debris. If necessary, clean the tubing to remove the debris. Replace any damaged tubing. 6. The ideal humidity setting depends on room temperature and humidity. Initially, a setting of 2 is recommended. You can adjust this setting at any time. Press and hold the humidifier button on the therapy device. The humidifier symbol and setting will appear. Press the + or - buttons to change the setting. IMPORTANT: 3.6 Setup Example When the airflow is turned off, the humidifier will automatically shut off. If you restart the airflow, the heated humidification will return to the previous setting. Loss of power to the system will require the user to press the heated humidifier button to reactivate the humidifier. Figure 3 8 shows an example of how you should route your tubing and situate your device on your night stand for the best setup possible. This will help prevent the device from falling off your night stand or table. Figure 3 8 Recommended Device and Tubing Placement 16
Chapter 4: Device Operation This chapter explains how to start the device and change the settings. NOTE: The numbers shown in the screens throughout this manual are examples only. Actual numbers will vary. 4.1 Starting the Device 1. Plug the device in to an AC power source. The HEAT, RAMP and START/STOP buttons light up and the Software Version screen momentarily appears, shown in Figure 4 1. Figure 4 1 Software Version Screen 2. The next screen to appear is the Standby screen, shown in Figure 4 2. See Section 4.5 for instructions on how to navigate the display screens. Figure 4 2 Standby Screen 3. Press the button to turn on the airflow. The altitude setting screen will appear for approximately one second. Put on your mask assembly when the air starts to flow. 4. The Operate screen appears, shown in Figure 4 3. Figure 4 3 Operate Screen The Operate screen shows the current CPAP setting. 17
5. Make sure that no air is leaking from your mask into your eyes. If it is, adjust the mask and headgear until the air leak stops. See the instructions provided with your mask for more information. NOTE: A small amount of mask leak is normal and acceptable. Correct large mask leaks or eye irritation from an air leak as soon as possible. 6. If you are using the device in bed, try placing the tubing from the device over your headboard. This may reduce tension on the mask. NOTE: NOTE: If you are having trouble with your mask, refer to the instructions supplied with the mask. You must remove the mask and patient circuit before you get out of bed. 4.2 Using the Ramp Feature You can press the RAMP this feature. button to activate the Ramp feature, if your provider has enabled 4.2.1 Ramp Feature The device is equipped with an optional ramp feature that your home care provider can enable or disable. This feature reduces the air pressure when you are trying to fall asleep and then gradually increases (ramps) the pressure until your prescription setting is reached, allowing you to fall asleep more comfortably. If ramp is enabled on your device, after you turn on the airflow, press the RAMP button on the top of the device. You can use the RAMP button as often as you wish during the night. NOTE: If the ramp feature is disabled, nothing will happen when you press the RAMP button. 4.2.2 Setting Ramp This screen is entered by pressing and holding the RAMP button for 3 seconds. The Ramp Starting Pressure Screen will appear, Figure 4-4. It can be entered from either the standby or operate screen. Figure 4-4 Ramp Starting Pressure Screen You can increase or decrease the ramp starting pressure in 0.5 cm H 2 O increments by pressing the + or buttons. The default setting is 4 cm H 2 O. You can adjust the setting from 4 cm H 2 O to the CPAP pressure setting. NOTE: This screen will not display if your provider has not enabled Ramp on your device. After you have finished modifying this screen, press the screen. button to return to the Standby 18
4.3 Using the Heated Humidifier Features 4.3.1 Heated Humidifier Feature The Integrated Heated Humidifier is a feature that may reduce nasal dryness and irritation by adding moisture and heat to the airflow. This feature can be enabled or disabled by your home care provider. 4.3.2 Setting Heated Humidifier If the heated humidifier is enabled on your device, press the HEAT button on the top of the device. The Heat Setting screen will appear, Figure 4-5. You can enter this screen from either the standby or operate screen. NOTE: If the heated humidifier feature is disabled by the home care provider, nothing will happen when you press the HEAT button. Figure 4-5 Heat Setting Screen You can increase or decrease the humidifier heat settings by pressing the + or buttons. The possible settings are from 0 (off) to 5 which is the highest setting. NOTE: This screen will not display if your provider has not enabled the humidifier on your device. After you have finished modifying this screen, press the screen. button to return to the Standby 4.4 Altitude Setting To access the Altitude Setting screen, you press and hold both the RAMP button and the HEAT button simultaneously for 3 seconds. The Altitude Setting screen will then appear, Figure 4-6. NOTE: You can only enter this screen from the standby screen. Figure 4-6 Altitude Setting Screen 19
This screen allows you to modify the altitude adjustment setting. Press the + or buttons to increase or decrease the setting by increments of 1: 1 = less than <2500 ft. 2 = 2500 ft. to 5000 ft. 3 = 5000 ft. to 7500 ft. NOTE: Elevations over 7500 ft. may affect the accuracy of the pressure. WARNING: If you incorrectly set the manual altitude setting, the pressure may be too high or too low, depending on your location. 4.5 Display Screens You can view the set pressure on the Active Display screen (Operate screen), as well as the following information on the Patient Data screens: Therapy usage hours (standby screen) Blower hours Number of sessions greater than 4 hours Compliance checksum Current altitude setting 4.5.1 Navigating the Display Screens Use the + and - buttons to navigate the display screens. NOTE: You can only enter these screens from the standby screen. 4.5.2 Viewing Data on the Patient Data Screens The following describes the Patient Data screens. 1. Therapy Usage Hours (Standby Screen) This screen displays the amount of time that the device provided therapy (with the blower on and the patient connected). The decimal digit is displayed if user hours are less than 10000 so it can be displayed with 0.1 hour resolution. Otherwise, the values between 10000 and 99999 hours can be displayed. Note: This screen is only for reference. Your home care provider may periodically ask you for this information. 20
2. Blower Hours Screen This screen displays the amount of time that the blower has been active over the life of the device. The decimal digit is displayed if user hours are less than 10000 so it can be displayed with 0.1 hour resolution. Otherwise, the values between 10000 and 99999 hours can be displayed. Note: This screen is only for reference. Your home care provider may periodically ask you for this information. 3. Session Counter Screen This screen displays the number of device therapy sessions that exceeded 4 hours. Note: This screen is only for reference. Your home care provider may periodically ask you for this information. 4. Compliance Check Screen This screen shows you the Compliance Check Value. Note: 4.6 System Error Screen Your home care provider may periodically ask you for this information. 5. Altitude Setting Screen This screen shows you the current altitude adjustment setting. The value will either be 1, 2 or 3: 1 = less than <2500 ft. 2 = 2500 ft. to 5000 ft. 3 = 5000 ft. to 7500 ft. When the unit detects a system error, the System Error screen is displayed as shown in Figure 4-7. The blower is turned off and pushbutton functions are disabled. Refer to Chapter 5: Alerts and Troubleshooting for more information. Figure 4 7 System Error Screen 21
Chapter 5: Alerts and Troubleshooting This chapter describes the device alerts and also provides troubleshooting information for issues you may run into when using the device. 5.1 Device Alerts The device provides two alert levels, high and medium priority. High Priority These alerts require immediate operator response. The alert signal is the backlights on the buttons providing a high priority flashing pattern consisting of a continuous, bright-to-off, two-flash pattern (indicated in the following table as: ). Alert Summary Table The following table summarizes the priority alerts. Al e r t Vi s u a l In d i c a t o r System Error Backlights: The following symbol displays to indicate that service is required: Device Action Possible Cause Patient Action The device enters the Safe state in which the device power remains on, but the airflow is disabled and the humidifier is turned off. Device failure Remove the power supply cord from the device to remove power. Plug the cord back into the device s power inlet to restore power. If the alert continues to occur, contact your home care provider. 5.2 Tr o u b l e s h o o t i n g The table below lists some of the problems you may experience with your device or mask and possible solutions to those problems. Problem Why It Happened What to Do Nothing happens when you apply power to the device. The backlights on the buttons do not light. There s no power at the outlet or the device is unplugged. If you are using AC power, check the outlet power and verify that the device is properly plugged in. Make sure the AC power cord is connected correctly to the power supply and the power supply cord is securely connected to the device s power inlet. If the problem continues to occur, contact your home care provider. Return the device to your provider, so they can determine if the problem is with the device. 22
Problem Why It Happened What to Do The device does not operate when you press the button. The airflow does not turn on. The device s display is erratic. Device Resets/Reboots: The device shuts down and restarts automatically during therapy. (This is unlikely to occur.) There may be a problem with the blower. The device has been dropped or mishandled, or the device is in an area with high Electromagnetic Interference (EMI) emissions. The device comes installed with troubleshooting software that automatically monitors performance. Make sure the device is powered correctly. If the button backlights turn on when you apply power, but the airflow does not turn on, there may be a problem with your device. Contact your home care provider for assistance. Note: When the device is functioning correctly, after you press the button, the airflow turns on after a slight delay. This brief delay is normal. Unplug the device. Reapply power to the device. If the problem continues, relocate the device to an area with lower EMI emissions (e.g., away from electronic equipment such as cellular phones, cordless phones, computers, TVs, electronic games, hair dryers, etc.). If the problem still occurs, contact your home care provider for assistance. Such a reset poses no danger to the patient and assures that the patient receives prescribed therapy throughout the night. If there is a possibility of damage to the device, the device will shut down permanently. The product will then display the following system error alert symbol to indicate that the device be returned to the home care provider for service: The Ramp feature does not work when you press the Ramp button ( ). The air out of the mask is much warmer than usual. Your home care provider did not prescribe Ramp for you, or your CPAP pressure is already set to the minimum setting. The air filters may be dirty. The device may be operating in direct sunlight or near a heater. If Ramp has not been prescribed for you, discuss this feature with your home care provider to see if they will change your prescription. If your provider has enabled Ramp, but the feature still does not work, check the CPAP setting on your Active Display screen. If CPAP is set to the minimum setting (4.0 cm H 2 O), or the starting pressure is the same as the prescribed pressure, the Ramp feature will not work. Clean or replace the air filters as described in Chapter 7. The temperature of the air may vary somewhat based on your room temperature. Make sure that the device is properly ventilated. Keep the device away from bedding or curtains that could block the flow of air around the device. Make sure the device is away from direct sunlight and heating equipment. If the problem continues, contact your home care provider. 23
Problem Why It Happened What to Do The device has fallen off your table or night stand. Air leaks from the vent hole on top of the water chamber. The device may not have been properly seated on the night stand, or the placement of the tubing may have caused the device to fall. Improperly assembled flapper (soft) valve. Always make sure your device is placed on a hard, flat surface so the rubber feet on the bottom of the device can adhere to the surface (make sure there is no fabric under the device). The device must be level for proper operation. Also, place the device away from the edge of the night stand or table, so it doesn t accidentally get knocked off the table. Make sure that the device with humidifier is placed below your head and mask, so that any condensation in the tubing drains back into the water chamber. If the device with humidifier fall and water gets into the device, drain all water out of the device and make sure it is completely dry before reapplying power. If the placement of the tubing causes the device to fall, make sure that you use proper hose management when setting up your device. Route the tubing behind the bed s headboard, as shown in Chapter 3, Setup. If the device falls or water gets into the device upon falling, let the device dry completely before restarting it. If the device does not operate correctly after falling, contact your home care provider. Remove water chamber and ensure that the flap of the valve operates freely. Reassemble system. The mask feels uncomfortable to wear, there is significant air leakage around the mask, or you experience other mask-related issues. You have a runny nose. Damaged soft valve. This could be due to improper headgear adjustment or improper mask fitting, etc. This is caused by a nasal reaction to the airflow. Replace soft valve. If you experience any issues with your mask, refer to your mask instructions for information on proper fitting, etc. If the problem continues, contact your home care provider. Call your health care professional. You have throat or nose dryness. The air is too dry. Increase the room humidity. When using the humidifier, refer to the instructions to make sure the humidifier is working properly. You experience nasal, sinus, or ear pain. You may have a sinus or middle ear infection. Stop using the device and contact your health care professional. 24
Chapter 6: Accessories Contact your home care provider for additional information on the accessories available for your SleepEasy system. When using optional accessories, always follow the instructions enclosed with the accessories. 6.1 Adding Supplemental Oxygen Oxygen may be added at the mask connection, as shown in Figure 6-1. Please note the warnings listed below when using oxygen with the device. Flexible Tubing Pressure Valve To Controlled Oxygen Source Figure 6-1 Respironics Pressure Valve with Oxygen Example Wa r n i n g s When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen. When using oxygen with this system, a Respironics Pressure Valve must be placed in-line with the patient circuit. Failure to use the pressure valve could result in a fire hazard. Oxygen accelerates fires. Keep the device and the oxygen container away from heat, open flames, any oily substance, or other sources of ignition. Do not smoke in the area near the device or the oxygen. When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen off before turning the device off. This will prevent oxygen accumulation in the device. If administering fixed-flow supplemental oxygen, the oxygen concentration may not be constant. The inspired oxygen concentration will vary, depending on the CPAP setting, patient breathing pattern, and leak rate. Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations. Appropriate patient monitoring should be implemented. 25
6.2 Traveling with the System For your convenience at security stations, there is a note on the bottom of the device stating that it is medical equipment. It may be helpful to bring this manual along with you to help security personnel understand the SleepEasy device. A travel bag is available as an accessory for the SleepEasy device. Contact Respironics to find out more information on the travel bag. NOTE: Before traveling, you must completely empty and dry the water chamber. NOTE: The water chamber must be detached from the unit while traveling. NOTE: Make sure the soft valve is safely secured to protect from any damage that may occur while traveling. 6.2.1 International Travel If you are traveling to a country with a line voltage different than the one you are currently using, a different power cord or an international plug adaptor may be required to make your power cord compatible with the power outlets of the country to which you are traveling. Contact your home care provider for additional information. 26
Chapter 7: Cleaning and Maintenance This chapter describes how to clean the device and its filters and provides tips on traveling with your SleepEasy system. 7.1 Cleaning the Device WARNING: To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. CAUTION: Do not immerse the device in liquid or allow any liquid to enter the enclosure, inlet filter, or any opening. 1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild detergent. Let the device dry completely before plugging in the power cord. 2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts. 7.2 Cleaning or Replacing the Filters CAUTION: Operating the device with a dirty filter may keep the system from working properly and may damage the device. Under normal usage, you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months. The white ultra-fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty. DO NOT clean the ultra-fine filter. CAUTION: Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly examine the inlet filters as needed for integrity and cleanliness. 1. If the device is operating, stop the airflow by pressing the button. Disconnect the device from the power source. 2. Remove the filter(s) from the enclosure by gently squeezing the filter in the center and pulling it away from the device. 3. Examine the filter(s) for cleanliness and integrity. 4. Wash the gray foam filter in warm water with a mild detergent. Rinse thoroughly to remove all detergent residue. Allow the filter to air dry completely before reinstalling it. If the foam filter is torn, replace it. (Only Respironics-supplied filters should be used as replacement filters.) 5. If the white ultra-fine filter is dirty or torn, replace it. 6. Reinstall the filters, inserting the white ultra-fine filter first if applicable, refer to chapter 3. CAUTION: Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter. 27
7.3 Cleaning the Tubing Clean the tubing daily. Disconnect the flexible tubing from the device. Gently wash the tubing in a solution of warm water and a mild detergent. Rinse thoroughly. Air dry. 7.4 Cleaning the Water Chamber Refer to Figure 7-1 when cleaning the water chamber. Flapper (Soft) Valve (Hand wash only!) Protective Cover (Hand wash only!) Water Chamber with Removable Base Plate Figure 7 1 Cleaning the Water Chamber NOTE: The Flapper (Soft) Valve has a one year lifespan. You must replace this valve after one year. NOTE: Hand washing can be performed daily. Dishwashing can be performed once a week. WARNING: Empty and clean the water chamber daily to prevent mold and bacteria growth. WARNING: Allow the water in the chamber to cool to room temperature before removing the chamber from the humidifier. 1. Turn the therapy device off and allow approximately 15 minutes for the heater plate and water to cool. 2. Disconnect the tubing from the water chamber. 3. Slide the water chamber out of the humidifier platform. Empty any remaining water. 4. Gently remove the base of the chamber with your hands, being careful not to damage the rubber seal. 5. Remove the flapper valve from the air inlet port; unclip the protective cover from the top of the water chamber. Wash these two parts by hand only in a solution of warm water and mild dishwashing soap. Rinse with clean water and allow them to air dry. 28
6. Wash the water chamber and base plate in the dishwasher (top shelf only) or by hand in a solution of warm water and mild dishwashing soap. 7. Inspect all parts for damage prior to reassembly. 8. Reassemble the water chamber. Make sure the base plate is fully seated on the water chamber. Also, make sure you install the flapper valve properly into the air inlet port of the water chamber. See Figure 7-1. NOTE: Be sure to reinstall the protective cover on top of the water chamber to prevent debris from entering the water chamber. 9. Fill the water chamber to the fill line. Inspect the water chamber for any leaks or damage. Replace the water chamber if any damage is present. 7.5 Se r v i ce The SleepEasy device does not require routine servicing. WARNING: If you notice unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if the enclosure is broken, or if water has entered the device, discontinue use, and contact your home care provider. 29
Chapter 8: Specifications Environmental Op e r a t i n g St o r a g e Te m p e ra t u r e 41 F to 95 F -4 F to 140 F Relative Humidity 15 to 95% (non-condensing) 15 to 95% (non-condensing) Atmospheric Pressure 77 to 101 kpa (0-7500 ft) N/A Physical Dimensions: Weight: Water Capacity: 10 L x 7.5 W x 5.5 H (25 x 19 x 14 cm) Approximately 3.5 lbs 350 ml at recommended water level Standards Compliance This device is designed to conform to the following standards: IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment EN ISO 17510-1 Sleep Apnea Breathing Therapy Devices EN ISO 8185 General Requirements for Humidification Systems El e c t r i c a l AC Power Consumption: Type of Protection Against Electric Shock: 100 240 VAC, 50/60 Hz, 2.7 A max. Class II Equipment Degree of Protection Against Electric Shock: Type BF Applied Part Degree of Protection against Ingress of Water: Device: Drip Proof, IPX1 Mode of Operation: Continuous Electromagnetic Compatibility: The device meets the requirements of EN 60601-1-2, 2nd edition. Heater Settings: 0 = off 1 = 113 F 2 = 122 F 3 = 131 F 4 = 140 F 5 = 149 F LED Type: Type 1 per IEC 60825-1. Fuses: There are no user-replaceable fuses. 30